Bivalirudin Monitoring in Pediatric Ventricular Assist Device and Extracorporeal Membrane Oxygenation: Analysis of Single-Center Retrospective Cohort Data 2018-2022
Engel ER, Perry T, Block M, Palumbo JS, Lorts A, Luchtman-Jones L (2024) · Pediatric Critical Care Medicine · n=22
Характеристика исследования
- Дизайн
- single-center retrospective laboratory validation study (Cincinnati Children's Hospital Medical Center, 2018-2022) - 115 VAD samples and 105 ECMO samples assessed
- Размер выборки (n)
- 22
- Вмешательство
- Bivalirudin-calibrated dilute thrombin time (Bival dTT) assay for anticoagulation monitoring in pediatric VAD and ECMO
- Компаратор
- Standard activated partial thromboplastin time (aPTT) assay
- Первичная конечная точка
- Correlation between Bival dTT, dTT, and aPTT vs bivalirudin plasma concentrations
- Основной результат
- Bival dTT excellent correlation with dTT (R²=0.86-0.87) and anti-IIa (R²=0.94); aPTT correlated poorly (R²=0.004-0.1); Bival dTT validated for clinical use
- Длительность наблюдения
- VAD/ECMO support duration
- PMID
- 38713010
Ключевые выводы
- aPTT correlates poorly with bivalirudin anticoagulant effect (R²=0.004-0.1)
- Bival dTT and dTT show excellent correlation with anti-IIa (R²=0.86-0.94)
- Provides validated alternative to aPTT for pediatric MCS monitoring
- Single institution can validate and clinically implement
- Opportunity for inter-institutional standardization
Ограничения
- Single-center retrospective design
- Small patient cohort (n=22)
- No correlation with clinical outcomes yet established
- Therapeutic range still requires determination
- Not applicable to whole-leech hirudotherapy
Клиническое значение
Engel 2024 addresses a critical laboratory monitoring gap for bivalirudin in pediatric mechanical circulatory support. For ASH, this work demonstrates the technical infrastructure required to safely deploy the synthetic thrombin inhibitor pharmaceutical pathway - sophisticated assays, single-institution validation, inter-institution standardization - structurally separate from the K040187 device-leech US clinical practice which requires no such monitoring infrastructure.
Связанные исследования
Hirulog in the treatment of unstable angina. Results of the Thrombin Inhibition in Myocardial Ischemia (TIMI) 7 trial
Fuchs J, Cannon CP (1995)
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW (2009)
Experience with pharmacologic leeching with bivalirudin for adjunct treatment of venous congestion of head and neck reconstructive flaps
Harun A, Kruer RM, Lee A, Boahene K, Byrne PJ, Richmon JD (2018)
Heparin and Bivalirudin in Percutaneous Coronary Intervention for Acute Coronary Syndromes: A Review Article
Wang G, Qi K, Li X, Zuo S, Zhang R, Zhao Y, Sun S, Zhang J, Liu X (2024)